Senior Manager, Analytical Development (Small Molecules)

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 135,000 - 201,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) match

Paid holidays and leave

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a senior analytical leader to oversee strategy and technical analytics across third party labs. The role drives method development, validation, and transfer for small molecules and peptides, ensuring GMP/GxP compliance and alignment with regulatory expectations.

You will collaborate across regulatory affairs, QA, and development teams to resolve complex issues, mentor staff, and deliver scientific insights that advance IND/NDAs and clinical milestones.

Qualifications

• Requires PhD or MSc with substantial pharma analytics experience in a GXP environment.
• Demonstrated leadership, communication, and stakeholder management skills.
• Experience with regulatory requirements and quality standards in drug development.

Responsibilities

• Lead analytical strategy and lab testing across CRO/CT labs.
• Develop/validate/transfer analytic methods for small molecules and peptides.
• Provide regulatory support and compile CMC sections.
• Mentor team members and ensure compliance with timelines and quality standards.

Skills

Analytical leadership

Regulatory communication

Cross-functional collaboration

MS Office/Excel

Mass spectrometry (MS)

Data review

GXP compliance

Education

PhD in analytical science/chemistry

Bachelor’s or Master’s in analytical science/chemistry

Tools

Mass spectrometry (MS)

MS Office (Excel)

Job description

Job Description

This role provides strategy and technical expertise to oversee analytical activities at third party laboratories, including method development/validation/qualification, stability testing, and investigational testing. In addition, there is responsibility to provide regulatory support from early phase drug development to commercial with technical aspects by developing analytical tools to gain understanding of key quality attributes in product and process for early to late phase synthetic small molecule, synthetic peptide, and/or other modalities. Collaborate cross-functionally with analytical team members, drug substance and drug product process development colleagues, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure compliance with applicable regulations and guidelines while maintaining alliance with internal timelines and corporate/project goals. Lead analytical activities such as method development, optimization and transfer for synthetic small molecules testing and characterization at CMO or contract testing labs. Provide actionable insights and recommendations to optimize project outputs for the project teams based on holistic analysis of the analytical projects including logistics, budgeting, method development through release testing and reporting. Monitor progress, identify potential risks, implement appropriate mitigation strategies, and ensure alignment with the strategic objectives. Lead the development and implementation of scientific strategies, ensuring alignment with regulatory requirements and industry best practices in the pharmaceutical field. Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity, and structure elucidation using mass spectrometry. Manage pharmaceutical stability studies, including protocols and timelines, for investigational new drug (IND) and new drug application (NDA) activities, ensuring compliance with regulatory guidelines and industry standards. Author technical reports and Chemistry, Manufacturing, and Controls (CMC) sections in regulatory documents. Mentor and train team members, fostering their professional growth and expertise in pharmaceutical analytical testing.

Qualifications

• Bachelor’s or master’s degree in analytical science, chemistry or related science + 10 years work experience or a Ph.D in analytical science, chemistry or related science + 5 years work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders
• Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards
• Experience with MS Office, especially MS Excel
• Experience in data review
• Must exhibit excellent oral and written communication skills

Preferred

• Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment
• Possess effective project management skills
• Sound judgement, decision-making skills, negotiation skills, and good organizational skills
• Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products
• Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry
• Hands on experience in method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience
• Proficiency in a broad spectrum of structure elucidation and physiochemical techniques including MS, UV, NMR, FTIR, etc.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents

Compensation

Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Equal Opportunity

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

About Otsuka

Otsuka is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.